Ignite Creation Date:
2024-05-05 @ 9:42 PM
Last Modification Date:
2024-10-26 @ 10:08 AM
Study NCT ID:
NCT00943839
Status:
COMPLETED
Last Update Posted:
2016-11-10
First Post:
2009-07-21
Brief Title:
Sunitinib Malate in Treating Patients With Kidney Cancer
Sponsor:
Centre Antoine Lacassagne
Organization:
Centre Antoine Lacassagne
Study Overview
Official Title:
Effects of Sunitinib in the Expression of VEGF and of Interleukin 6 and CXCL7 - CXCL5 Cytokins Explanation of Anti-angiogenic Effects
Status:
COMPLETED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor
PURPOSE This clinical trial is studying how well sunitinib malate works in treating patients with kidney cancer
PURPOSE This clinical trial is studying how well sunitinib malate works in treating patients with kidney cancer
Detailed Description:
OBJECTIVES
Primary
To determine whether a link exists between the effectiveness of therapy with sunitinib malate and development of blood biomarkers specifically the angiogenic factors VEGF and interleukin-8 IL-8 in patients with kidney cancer
Secondary
To evaluate the link between the time to progression and the development of VEGF and IL-6 CXCL7 and CXCK5 blood levels in these patients
To evaluate the link between VEGF and IL-6 CXCL7 and CXCK5 blood levels and disease-free survival of these patients after 3 6 9 and 12 months of treatment
To evaluate the link between VEGF and IL-6 CXCL7 and CXCK5 blood levels and overall survival of these patients
OUTLINE This is a multicenter study
Patients receive oral sunitinib malate once daily on days 1-28 Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
Blood samples are collected at baseline and then every 6 weeks for pharmacokinetic analysis
Primary
To determine whether a link exists between the effectiveness of therapy with sunitinib malate and development of blood biomarkers specifically the angiogenic factors VEGF and interleukin-8 IL-8 in patients with kidney cancer
Secondary
To evaluate the link between the time to progression and the development of VEGF and IL-6 CXCL7 and CXCK5 blood levels in these patients
To evaluate the link between VEGF and IL-6 CXCL7 and CXCK5 blood levels and disease-free survival of these patients after 3 6 9 and 12 months of treatment
To evaluate the link between VEGF and IL-6 CXCL7 and CXCK5 blood levels and overall survival of these patients
OUTLINE This is a multicenter study
Patients receive oral sunitinib malate once daily on days 1-28 Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
Blood samples are collected at baseline and then every 6 weeks for pharmacokinetic analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CALACASS-SUVEGIL-8 | None | None | None |
| 200820 | None | None | None |
| INCA-RECF0943 | None | None | None |
| EUDRACT-2008-004137-21 | None | None | None |